Core Insights - Baiyue Shenzhou's bispecific HER2 inhibitor, Zhenidamab (百赫安), received conditional approval from the National Medical Products Administration (NMPA) for treating HER2-positive advanced or metastatic biliary tract cancer (BTC) patients who have previously undergone systemic therapy [1][2] - This approval marks Zhenidamab as the first and only bispecific antibody approved in China for targeted therapy of HER2-positive biliary cancer, providing a new treatment option for patients [1][2] - The incidence of biliary tract cancer is on the rise, with approximately 15% to 30% of BTC patients exhibiting HER2 abnormalities, making HER2 a key target for BTC treatment [1] Clinical Data - The conditional approval is based on the results of the global multicenter clinical study HERIZON-BTC-01, which showed an objective response rate (ORR) of 51.6% in previously treated, unresectable HER2-positive advanced or metastatic BTC patients [2] - The median duration of response (mDoR) was 14.9 months, and the median overall survival (mOS) was 18.1 months, indicating a significant improvement in survival compared to previous second-line chemotherapy options [2] - The safety profile of Zhenidamab was reported to be favorable, demonstrating good overall safety [2] Mechanism of Action - Zhenidamab utilizes a dual-targeting mechanism by binding to two different non-overlapping epitopes of the HER2 protein, enhancing its binding and inhibitory capabilities, which may lead to a synergistic effect in tumor suppression [2] - This innovative mechanism allows for dual signal blockade and the formation of larger receptor clusters, potentially improving therapeutic efficacy [2] Strategic Collaboration - Zhenidamab was developed by Zymeworks, with Baiyue Shenzhou entering a strategic partnership for its development and commercialization in Asia (excluding Japan), Australia, and New Zealand [3] - The drug is also set to be available in the United States, having received FDA approval for the same indication in November 2024 [3] - The President and COO of Baiyue Shenzhou expressed confidence that this innovative drug will significantly benefit the survival of BTC patients in China [3]

Core Insights - Chinese innovative pharmaceutical company 3SBio has entered a record-breaking License out agreement with Pfizer, potentially worth up to $60.5 billion (approximately 435 billion RMB) [1] - This transaction sets a new record for the amount of a single product going overseas from a Chinese pharmaceutical company and highlights the strong emergence of Chinese innovative drug companies in the global bispecific antibody market [1] Transaction Details - The agreement grants Pfizer the rights to develop, produce, and commercialize 3SBio's self-developed PD-1/VEGF bispecific antibody SSGJ-707 in global markets outside mainland China [2] - Pfizer will pay an upfront fee of $12.5 billion (approximately 90 billion RMB) and up to $4.8 billion in milestone payments, along with a double-digit percentage tiered revenue share from sales in the licensed regions [2] - All payments are non-refundable and non-offsettable, and Pfizer retains the option to commercialize the product in mainland China [2] Product Advantages - SSGJ-707 is developed based on 3SBio's proprietary CLF2 platform, featuring a common light chain symmetrical design and IgG-like structure, which significantly reduces production costs and enhances efficiency [3] - Clinical data shows promising anti-tumor activity and safety: - Objective response rate (ORR) of 70.8% and disease control rate (DCR) of 100% for PD-L1 positive non-small cell lung cancer (NSCLC) [3] - ORR of 81.3% for squamous NSCLC and 58.3% for non-squamous NSCLC, with DCR at 100% when combined with chemotherapy [3] - Adverse event rates for grade 3 or higher treatment-related adverse events (TRAE) range from 8.9% to 23.5%, significantly lower than similar products [3] Market Outlook - The PD-1/VEGF bispecific antibody market is expected to explode, with Evaluate Pharma predicting a global market size exceeding $80 billion by 2030 [5] - Currently, only Kangfang Biotech's Ivosidenib is on the market, and 3SBio's rapid advancement positions it to seize market opportunities [5] Industry Trends - The total value of License out transactions for Chinese innovative drugs reached $51.9 billion in 2024, a year-on-year increase of 27.4%, accounting for 30% of global similar transactions [6] - In the first quarter of 2025, Chinese companies completed 41 overseas transactions totaling over $36.9 billion, with a growing proportion of "heavyweight transactions" [6] - This collaboration further confirms the transition of Chinese innovative drug companies from "followers" to "leaders" in the global market [6] Industry Outlook - This transaction not only brings substantial cash flow to 3SBio but also highlights the maturity of Chinese pharmaceutical companies in target selection, clinical design, and international collaboration [7] - As more original Chinese drugs enter the global market, the "two-way rush" between multinational and Chinese pharmaceutical companies may become the new norm, accelerating the gathering of global pharmaceutical innovation resources in China [7] Conclusion - The collaboration between 3SBio and Pfizer marks a significant milestone for Chinese innovative drugs going global, transitioning from "Made in China" to "Created in China" [8] - With support from policies, capital, and technological breakthroughs, Chinese pharmaceutical companies are entering a golden era of License out, potentially reshaping the global pharmaceutical market landscape [8]

Group 1 - The core point of the article is the licensing agreement between 3SBio and Pfizer for the development and commercialization of SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, with an upfront payment of $1.25 billion and potential milestone payments of up to $4.8 billion [1][2] - SSGJ-707 has shown promising clinical results in non-small cell lung cancer (NSCLC) with high objective response rates (ORR) and disease control rates (DCR), indicating its best-in-class potential [2] - The drug has received breakthrough therapy designation from the National Medical Products Administration (NMPA) in China and IND approval from the FDA, with ongoing clinical studies for other cancers [2] Group 2 - The company expects steady growth in its core products, including Tezspire and Mandi, in 2024, along with expansion in indications and formulations [3] - The company has established four new collaborations in 2024, enhancing its commercial footprint and product portfolio [3] - Revenue forecasts for the company have been adjusted upwards, with projected total revenues of 18.244 billion, 12.752 billion, and 14.731 billion yuan for 2025-2027, and corresponding net profits of 8.575 billion, 3.413 billion, and 4.102 billion yuan [3]

Group 1 - The stock of Sanofi Guojian (688336) experienced a significant drop of over 10% during trading on the 23rd, following a continuous rise of 100% over the previous four trading days [1] - The company issued a risk warning on May 22, indicating the potential for irrational speculation and a market correction due to the substantial increase in stock price [1] - The trading volume exceeded 530 million yuan, reflecting heightened market activity [1] Group 2 - The company, along with its affiliates, granted Pfizer Inc. exclusive rights for the development, production, and commercialization of a dual-targeting antibody product (Project 707) outside of mainland China [2] - The revenue sharing from this licensing agreement is set at 30% for Sanofi Guojian and 70% for Shenyang Sanofi, based on prior R&D investments and asset ownership [2] - The agreement requires approval from the company's shareholders and antitrust regulatory bodies in the U.S. and other jurisdictions, introducing uncertainty regarding its effectiveness [2] Group 3 - The development, registration, and sale of the licensed product in the designated regions are subject to regulatory approvals, which are inherently uncertain due to the lengthy nature of new drug development [3] - Milestone payments tied to clinical and regulatory events are contingent upon the successful completion of specified conditions, adding another layer of uncertainty [3] - Sales milestone payments and royalties are dependent on market factors such as demand, competition, and sales channels, which may affect the actual revenue received by the licensing parties [3]

Core Viewpoint - Sangfor Biopharma (三生国健) has announced a collaboration with Pfizer for the development of project 707, a bispecific antibody targeting both PD-1 and VEGF, with potential uncertainties regarding milestone payments and royalties based on sales performance [1] Group 1 - Sangfor Biopharma's stock has experienced significant volatility, with a cumulative price deviation exceeding 30% over two trading days and 100% over four trading days, indicating abnormal trading activity [1] - The collaboration grants Pfizer exclusive rights to develop, produce, and commercialize the 707 project in regions outside mainland China for both human and veterinary applications [1] - The payment of milestone payments and royalties is contingent upon achieving specified sales targets, introducing uncertainty regarding the actual amounts received by the licensing parties [1] Group 2 - The sales performance of the licensed product may be influenced by various factors, including drug demand, market competition, and sales channels, contributing to the uncertainty surrounding the financial outcomes of the collaboration [1]

Core Viewpoint - The collaboration between Sanofi and Pfizer for the dual-specific antibody SSGJ-707 marks a significant step in the global commercialization of innovative cancer therapies, enhancing the international recognition and accessibility of Sanofi's products [1][2]. Company Summary - Sanofi and its affiliates granted Pfizer exclusive global rights (excluding mainland China) for the development, production, and commercialization of the dual-specific antibody SSGJ-707, with Pfizer retaining rights for commercialization in mainland China through additional payments [1]. - Pfizer will pay an upfront non-refundable fee of $1.25 billion, with potential milestone payments reaching up to $4.8 billion based on development, regulatory approval, and sales, along with a double-digit percentage sales share based on product sales in authorized regions [1]. - The antibody SSGJ-707 targets PD-1 and VEGF, having received breakthrough therapy designation from the National Medical Products Administration for treating advanced non-small cell lung cancer (NSCLC) [1][2]. Industry Summary - The collaboration signifies recognition of Sanofi's dual-specific antibody research platform by a leading international company, which is expected to enhance the global reach and acceptance of its products [2]. - The SSGJ-707 is currently in Phase III clinical trials for NSCLC and Phase II for other indications, indicating a robust pipeline for Sanofi's innovative therapies [2]. - The trend of Chinese innovative drug companies entering into licensing agreements with multinational pharmaceutical companies is growing, driven by the increasing recognition of Chinese innovation and the need for multinational firms to address patent cliffs [3][4].

Summary of Key Points Core Viewpoint - The announcement details a licensing agreement between Sangfor Health (Shanghai) Co., Ltd. and its affiliates, granting Pfizer Inc. exclusive rights to develop, produce, and commercialize a dual-specific antibody product targeting PD-1 and VEGF outside of mainland China, with potential commercialization rights in mainland China under certain conditions [1][5][11]. Group 1: Transaction Overview - The transaction involves a licensing agreement that allows Pfizer to exclusively develop, produce, and commercialize the licensed product in specified regions and fields [1][3]. - The revenue from the agreement will be shared based on the initial R&D investments and asset ownership, with Sangfor Health receiving 30% and Shenyang Sangfor receiving 70% [1][5]. - The agreement is classified as a related party transaction, requiring approval from the company's shareholders and regulatory bodies [2][5]. Group 2: Product Details - The licensed product is a dual-specific antibody that targets PD-1 and VEGF, developed through a collaboration between Sangfor Health and Shenyang Sangfor [5][11]. - The product aims to enhance anti-tumor effects while reducing potential side effects compared to combination therapies, with ongoing clinical trials for various cancer types [5][11]. Group 3: Counterparty Information - Pfizer Inc. is a multinational biotechnology and pharmaceutical company based in the United States, listed on the New York Stock Exchange [6]. - Sangfor Health is a subsidiary of Sangfor Pharmaceutical, which holds a significant stake in the company [6][7]. Group 4: Financial Terms - The financial terms of the agreement include an upfront payment, milestone payments, and royalties based on annual net sales in the licensed regions [11][12]. - The total potential payments to be made by Pfizer could reach up to $4.8 billion, contingent on achieving specific development and sales milestones [11][12]. Group 5: Approval and Compliance - The agreement is subject to approval from the company's shareholders and must comply with antitrust regulations in the U.S. and other jurisdictions [2][5]. - The effectiveness of the licensing agreement is contingent upon meeting several conditions, including the approval of the shareholders' meeting and the establishment of a supply agreement for clinical trials [12][14].

Core Viewpoint - The biotech sector, particularly companies involved in monoclonal antibody cancer therapies, experienced significant stock price volatility due to competitive developments, particularly the FDA approval of Akeso's cancer drug [1][2]. Group 1: Company Developments - Summit Therapeutics saw its shares drop by 36.1% following the news of Akeso's FDA approval, despite having positive phase 3 trial data for ivonescimab [1][5]. - BioNTech's shares fell by 15.4%, likely influenced by the competitive landscape as Akeso's drug received approval while BioNTech's drugs remain in late-stage trials [1][7]. - Akeso's penpulimab-kcqx received FDA approval for treating nasopharyngeal carcinoma, and ivonescimab was approved in China for PD-L1-positive non-small cell lung cancer [3][4]. Group 2: Competitive Landscape - Akeso's approval of its cancer drugs has created a competitive challenge for Summit, especially since Akeso holds rights to ivonescimab in China [4][5]. - The approval of Akeso's drugs may allow it to explore additional cancer treatments, potentially impacting Summit's market position [6]. - The rapid developments in the bispecific antibody space highlight the intense competition and uncertainty in the biotech industry, affecting investor sentiment towards companies like Summit and BioNTech [8].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） （股份代號：9966） 自願公告 JSKN003獲得國家藥監局突破性療法認定 1 關於JSKN003 JSKN003是一種靶向HER2雙表位ADC，其通過糖基定點偶聯技術將拓撲異構酶 I抑制劑連接至抗體KN026（重組人源化抗HER2雙特異性抗體）的N糖基化位點 處。點擊反應偶聯物較馬來醯亞胺－邁克爾反應的偶聯物具有更好的血清穩定 性。雙表位HER2靶向性使JSKN003具有更強的內吞誘導及旁觀者殺傷效應，使 其在HER2表達腫瘤中具有較強的抗腫瘤活性。 關於本公司 本公司是一家中國領先的生物製藥公司，在雙特異性抗體、多功能蛋白質工程及 ADC方面擁有完善的專有技術平台。本公司高度差異化的內部管線由處於不同研 發階段的腫瘤單克隆抗體、雙特異性抗體及ADC組成，包括一種已獲國家藥監局 批准上市及三種處於臨床後期階段的藥 ...